Lisa Moore, PhD, ISMPP CMPPTM; Karen King, PhD, ISMPP CMPPTM; Jason Gardner, PhD, ISMPP CMPPTM, of Complete Medical Communications, a McCann Health Company, UK
There is an expectation that pharmaceutical companies should responsibly share the data that are generated by interventional clinical trials [1], and many pharmaceutical companies have committed to publishing all clinical trial data in peer-reviewed journals [2]. In addition, timely publication of a manuscript in a “high-tier” journal is a key goal for many clinical researchers.
A high-tier journal is one with a long-standing reputation for publishing research of high quality, having a rigorous peer-review process, attracting extensive global medical readership, and focusing on novel findings that will have a major impact on general medical practice. As such, clinical research manuscripts published by high-tier journals typically describe robust, well-powered proof-of-concept or hypothesis-testing clinical studies concerning pharmaceutical therapies or other interventions that meet a significant unmet medical need (see Figure 1 below).
The principal benefit of publishing in a high-tier journal is the associated endorsement of quality and relevance, and that the research has – or could have – a substantial impact on improving outcomes for human lives. With this endorsement, and the broad global readership enjoyed by high-tier journals, the article is more likely to be read, recognized, and acted upon by the medical community, including physicians, payers, policy makers, and funding bodies. However, publishing in high-tier journals can be challenging, and these journals do have high rejection rates, typically as high as 95% [3–5].
Selecting an Appropriate Journal
Many authors consider the Impact Factor (IF) to be the most important feature when deciding on a target journal, with a high journal IF being synonymous with a high-tier journal (see Figure 2 below, for calculation of IF).
IF is generally perceived to generate credibility for the article and of the content therein, resulting in better exposure within the broad medical/scientific community. A key driver of journal selection for some academic authors is the prestige of publishing in a journal with a high IF, which may bolster an author’s reputation and that of the author’s institution. For medicine-based research, three of the “top” high-tier journals according to IF are The New England Journal of Medicine (N Engl J Med), The Lancet, and The Journal of the American Medical Association (JAMA).
However, in today’s digital age, IF is much debated, and it is helpful to also consider other factors when providing guidance to authors on the target journal choice, such as the time to publication (lead time), rejection rate, readership, publication frequency, and other “wider” features, such as the electronic IF (eg, the number of times a published manuscript is downloaded) and options for enhancing-reach materials offered by journals. Moreover, the type of content and its suitability for high-tier journal publication is key to making an appropriate choice. So, when considering publishing clinical research in a high-tier journal, it is usually helpful to conduct an analysis of recent publications in both the chosen journal and across other potential target journals, to assess suitability and novelty.
Editors of journals, including The Lancet, may solicit a request for submission of a manuscript after the congress presentation of the data in select circumstances, particularly after late-breaking data presentations. In the absence of such a request, another option to gauge a journal’s interest is to send a pre-submission inquiry – some journals actively encourage this [2]. Although a pre-submission inquiry may confirm alignment of the article with the scope of the journal, it will not provide any indication of the probability of acceptance, and it may generate false expectations by the authors of manuscript acceptance, if not managed appropriately.
Timelines and Planning, Including Contingency Planning
One of the other important considerations in appropriate journal selection is timing. Authors should assess such factors as the time needed for manuscript development and time estimates for submission-to-publication when selecting the target journal. Timing considerations are typically even more important when submitting to a high-tier journal, given the potential need to meet a specific publication date and/or achieve expedited peer-review timelines, often with a larger number of authors.
Publishing in a high-tier journal requires careful consideration and planning before, during, and after manuscript submission. Once the author list is confirmed, a manuscript development timeline is a critical tool [7], particularly when a specific publication date is desired, such as parallel publication alongside a release of data at a key scientific congress (which is most often the case for high-tier journal publications), or release of Phase III data in advance of product approval. Furthermore, it may be that your article forms part of a series of publications from a multi-trial Phase II or III clinical development program.
Upon establishing a dialog with the high-tier journal, it is worth having open discussions about the extent of the clinical development program with the journal editor, who may wish to publish articles from related studies concurrently and, thereby, provide greater context and impact to readers – sometimes with the addition of an associated editorial article. This may mean expediting the development of a publication or accepting the delay of another, if timelines for the studies are staggered. Alternatively, your article may be an interim analysis from an ongoing study or the first results from a series of sequential studies. Again, dialog with the editor will establish whether there is a preference to publish now or wait until the totality of the data are available. Authors should be prepared for these discussions through scenario planning and through alignment with authors across related publications.
Typically, development of a manuscript with multiple authors and facilitated by a professional medical writer can take six months or longer, depending upon the complexity and challenges concerning data and author alignment/approval of the content. Pivotal clinical trial publications in high-tier journals can often involve many more authors than other publications, so early author engagement in the planning and timelines for the manuscript is essential. Indeed, with author agreement and engagement, it is possible to expedite timelines to achieve submission within two months of the manuscript kick-off call (particularly when required for a specific scientific congress). Disagreements between authors in terms of manuscript plans and content can happen at any time during manuscript development, so a proactive (“unforeseen delay“) plan should be incorporated into development timelines.
As always, it is critical to ensure that both the manuscript and any supporting materials are written and prepared in accordance with journal guidelines; failure to do so will only waste time post-submission and may result in rejection. Similarly, some authors may want to take time pre-submission and during post-submission revisions to refine the language within a manuscript. However, it is important to note that most high-tier journals will make substantial post-approval edits to align the manuscript with their style, rendering extensive “beautification” of language redundant. There is also the maximum word count to consider; when the bulk of the word count is spent on the “Methods” and “Results” sections, it leaves little space for contextualization of the findings in the “Discussion” section. Consequently, judicious use of the supplementary materials for methods and results presentation may help to claw back space for important points concerning data interpretation.
Based on recent experiences, The Lancet has proved the best vehicle for publishing clinical data quickly. The journal’s “Information for Authors” states:
“For research papers, which will usually be randomized controlled trials, judged to warrant fast dissemination, The Lancet will publish a peer-reviewed manuscript within four weeks of receipt.”
In one example, the authors’ goal was for publication to coincide with an important international congress taking place three months after data availability. Although the target journal, in this case The Lancet, does not advertise a pre-submission inquiry option, a positive pre-submission dialog was established with the journal, and the (>20) authors agreed on several approaches to expedite development of the manuscript (see Figure 3 below). In addition, the authors agreed on a “back-up” journal, which meant the manuscript was styled for submission to The Lancet and, simultaneously, styled for submission to another journal, should the manuscript be rejected by The Lancet. Fortunately, the back-up journal was not required, but there were obvious resource (eg, cost) implications.
Figure 3. The Lancet case study: approaches used to meet the timeline challenge.
m/s = manuscript
Another important planning consideration, sometimes overlooked, is the need to factor in significant time for post-submission journal comments from some high-tier journals – particularly for N Engl J Med – even when authors have been invited to submit their data. In some cases, manuscripts describing Phase III primary data may take as long as 12 months to achieve publication in N Engl J Med following first submission. Although this is undesirable for situations in which speed to publication is key, it does suit circumstances in which the time from availability of Phase III pivotal study data to eventual product approval is approximately 18–24 months.
Extending the Reach of Your Publication
So, your manuscript has just been approved for publication – congratulations! While this is exciting news, you may already be too late if you have not already started preparing additional materials to extend the reach of the manuscript when it is published. Many high-tier journals offer additional facilities (also known as enhanced content) to bring your manuscript to life, including audio or video abstracts, animations, infographics, slides, lay summaries, and social media opportunities. Build these facilities into your planning (particularly into any budgetary considerations and the additional time required for review) to ensure that the return on investment is justified.
Summary
Publishing in a high-tier journal is a goal for many medical researchers, but potential challenges lie ahead, even with data that are worthy of publication in a high-tier journal. Many of these challenges can be overcome with careful planning before and during manuscript development, and by encouraging open and timely communication between the authors and with the target journal.
Remember: aim too high and you may incur spiraling costs and extended timelines through the need to restyle and resubmit to a back-up journal; aim too low and you may not achieve the impact that the data deserve. It is essential that these discussions occur as soon as possible, so authors are aligned in achieving a common goal.
References
- Taichman, et al. Ann Intern Med. 2016;164:505–506.
- Chipperfield, et al. Curr Med Res Opin. 2010;26:1967–1982.
- N Engl J Med. http://www.nejm.org/page/media-center/publication-process
- Lancet. http://www.thelancet.com/pb/assets/raw/Lancet/authors/tl-information-for-authors.pdf
- JAMA. https://jamanetwork.com/journals/jama/pages/for-authors#fa-why-publish
- Elsevier, Journal Authors. https://www.elsevier.com/authors/journal-authors/measuring-a-journals-impact
- Battisti, et al. Ann Intern Med. 2015;163:461–464.